WO2021260192A1 - Procédé et appareil pour évaluer le tonus artériel périphérique - Google Patents

Procédé et appareil pour évaluer le tonus artériel périphérique Download PDF

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Publication number
WO2021260192A1
WO2021260192A1 PCT/EP2021/067534 EP2021067534W WO2021260192A1 WO 2021260192 A1 WO2021260192 A1 WO 2021260192A1 EP 2021067534 W EP2021067534 W EP 2021067534W WO 2021260192 A1 WO2021260192 A1 WO 2021260192A1
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Prior art keywords
individual
volume
time
light
points
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PCT/EP2021/067534
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English (en)
Inventor
Wout Geeurickx
Frederik Massie
Steven Vits
Bart Van Pee
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Ectosense NV
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Priority to CN202180052412.8A priority Critical patent/CN115988984A/zh
Priority to US18/012,009 priority patent/US20230263453A1/en
Priority to AU2021295604A priority patent/AU2021295604A1/en
Priority to JP2022580956A priority patent/JP2023532318A/ja
Priority to IL299330A priority patent/IL299330A/en
Publication of WO2021260192A1 publication Critical patent/WO2021260192A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007Evaluating blood vessel condition, e.g. elasticity, compliance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026Measuring blood flow
    • A61B5/0261Measuring blood flow using optical means, e.g. infrared light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026Measuring blood flow
    • A61B5/0295Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/40Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4029Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
    • A61B5/4035Evaluating the autonomic nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4806Sleep evaluation
    • A61B5/4815Sleep quality
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4806Sleep evaluation
    • A61B5/4818Sleep apnoea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/07Home care
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6825Hand
    • A61B5/6826Finger

Definitions

  • the present invention generally relates, amongst others, to a method and an apparatus for assessing Peripheral Arterial Tone or PAT. More particularly, it relates to robustly monitoring peripheral arterial tone for detecting for example sleep-related events.
  • a cardiac cycle of an individual i.e. the period between two heart beats
  • blood is pumped through the vascular system of the individual in a pulsating fashion.
  • the volume of blood in for example a finger, a nostril, an ear, a forehead, the inside of a mouth, a toe, a wrist, an ankle, etc., increases and decreases cyclically.
  • the blood comprised in arteries is called arterial blood.
  • the blood comprised in veins is called venous blood.
  • a common method for measuring this fluctuation in blood volume is optical plethysmography, or photoplethysmography, during which an optical plethysmogram, or PhotoPlethysmoGram, or PPG, is used to detect changes in blood volume in the microvascular bed of the tissue.
  • a PPG is often obtained by shining light from one or more light sources, such as for example LEDs, onto an investigated volume, and detecting collected light corresponding to the light being reflected or transmitted in the investigated volume on a sensor, wherein the sensor may for example comprise or correspond to a photodetector, such as for example a photodiode.
  • the light sources and the sensor can for example be arranged on opposite sides of a finger of an individual, hereby allowing the measurement of a transmission mode PPG, or at the same side of a finger of the individual, hereby allowing the measurement of a reflectance mode PPG.
  • the heart pumps arterial blood to the investigated volume.
  • the physical events corresponding to a change in arterial blood volume in the investigated volume for example in a cardiac cycle can be captured by optical plethysmography.
  • the arterial blood volume in the tissue is also influenced by the diameters of small arteries, or arterioles, in the investigated volume. These arterioles have muscular walls which can contract to reduce the diameter arterioles. In other words, when these arterioles contract and reduce in diameter, the volume of blood comprised in the corresponding arterioles evidently reduces.
  • Optical plethysmography is a measurement technique which can be used to monitor changes in the volume of blood comprised in arterioles when these arterioles contract in diameter. Monitoring changes in the arterial blood volume with optical plethysmography therefore empirically provides information on relative changes in muscle tension or ‘tone’ of the smooth muscle tissue of the arterioles, also referred to as Peripheral Arterial Tone or PAT.
  • optical plethysmography can also be used to monitor breathing, hypovolemia, other circulatory conditions, and for example can be used for diagnosing sleep disorders.
  • Sleep disorder diagnosis is a medical field wherein a patient’s sleep is monitored during a certain time, e.g. one or more nights. Based on the monitoring, different sleep-related events may be identified such as for example apneic events, snoring, or limb movements.
  • This object is achieved, according to a first example aspect of the present disclosure, by a computer-implemented method for assessing peripheral arterial tone, PAT, of an individual monitored by optical plethysmography and for detecting therefrom occurrence of a sleep-related event at the individual, wherein the method comprises the steps of:
  • the computer-implemented method according to the present disclosure allows determining peripheral arterial tone in an accurate and robust manner.
  • the determination of changes in arterial blood volume in the investigated volume between two points in time with the computer-implemented method according to the present disclosure is more accurate than by monitoring changes in amplitude of pulses in the optical plethysmography signal. Therefore, with the computer-implemented method according to the present disclosure, it becomes possible to assess PAT of an individual more accurately and more robustly than with existing prior art solutions.
  • the resulting evaluation of changes in arterial blood volume in the investigated volume through the determination of a logarithm or a function approximation thereof of a function of the light intensities therefore provides a more accurate and robust assessment of peripheral arterial tone of the individual.
  • an investigated volume of an individual is for example a volume defined in an investigated tissue of the individual which is monitored by optical plethysmography and in which light emitted by optical plethysmography propagates and is collected on a sensor for optical plethysmography.
  • an investigated volume of an individual is for example a volume defined in an investigated tissue of the individual for which an optical plethysmography signal is acquired.
  • the investigated volume is a peripheral tissue volume of the individual.
  • the investigated volume is a volume defined in finger, a tip of a finger, a distal end of a digit of the individual, a nostril, an ear, a forehead, the inside of a mouth, a toe, a tip of a toe, a wrist, an ankle of the individual.
  • the investigated volume of an individual comprises the skin of the individual comprised in the investigated volume and further comprises the blood volume present in the investigated volume.
  • peripheral arterial tone is understood as arterial tone changes in investigated arterial beds in the investigated volume of an individual.
  • determining pulsatile volume changes in the vascular beds of the investigated volume of the individual allows determining or assessing information indicative for muscle tension or ‘tone’ of the smooth muscle tissue of the arterioles in the investigated volume and therefore allows determining or assessing peripheral arterial tone which is modulated by the sympathetic nervous system.
  • Determining peripheral arterial tone is non-invasive and can for example be used to detect heart diseases, erectile dysfunction, sleep apnea, obstructive sleep apnea, cardiovascular conditions, sleep related respiratory events, etc..
  • an optical plethysmography signal is a signal measured by optical plethysmography.
  • the optical plethysmography signal is an optical plethysmogram.
  • the optical plethysmography signal is a PPG.
  • the optical plethysmography signal is for example measured at the tip of a finger of the individual by an optical plethysmography setup comprising at least one light source and a sensor.
  • a light intensity corresponds to the intensity of light collected on the sensor of the optical plethysmography setup, wherein the light collected on the sensor corresponds to light generated by one or more light sources being transmitted through or reflected in the investigated volume of the individual.
  • the oxygen saturation estimate or SpC>2 or hemoglobin composition corresponds to a fraction of oxygenated hemoglobin related to a total amount of hemoglobin in the arterial blood volume in the investigated volume.
  • the oxygen saturation estimate or SpC>2 or hemoglobin composition corresponds to a ratio of the concentration of oxygenated hemoglobin on the sum of the concentrations of oxygenated and deoxygenated hemoglobin in the arterial blood volume being monitored in the investigated volume.
  • the oxygen saturation estimate or SpC>2 or hemoglobin composition corresponds to a ratio of the volume fraction of oxygenated hemoglobin on the sum of the volume fractions of oxygenated and deoxygenated hemoglobin in the arterial blood volume being monitored in the investigated volume.
  • deoxygenated hemoglobin is defined as the form of hemoglobin without the bound oxygen, and without any other bound molecule such as for example carbon monoxide, carbon dioxide, or iron.
  • oxygenated hemoglobin is defined as the form of hemoglobin with the bound oxygen.
  • light emitted by the light sources of an optical plethysmography setup comprises photons which reach the sensor through a probabilistic path of one or multiple scattering events. This optical path is not straight and is often assumed to follow a curved spatial probability distribution. The investigated volume along this curved optical path forms the volume which is sampled or investigated by optical plethysmography.
  • the computer- implemented method according to the present disclosure evaluates one or more changes in arterial blood volume in the investigated volume between the two or more points in time and hereby assessing PAT of the individual.
  • a change in arterial blood volume in the investigated volume between two points in time corresponds to a relative change between the volume of arterial blood present in the investigated volume at a first point in time and the volume of arterial blood present in the investigated volume at a second point in time different from the first point in time.
  • the blood comprised in arteries is called arterial blood.
  • the blood comprised in veins is called venous blood.
  • a chromophore is a molecular unit which absorbs or scatters light in the investigated volume.
  • examples of chromophores are melanin molecules, oxygenated hemoglobin, deoxygenated hemoglobin, etc.
  • the decay in light intensity of the incident light emitted by a light source of an optical plethysmography setup follows the Beer-Lambert law which can be formulated as in equation (1): wherein:
  • I 0 corresponds to the intensity of incident light emitted by a light source of an optical plethysmography setup
  • - comprises an absorption coefficient and/or a scattering coefficient and/or an extinction coefficient of chromophore /;
  • V t corresponds to either a volume fraction or a concentration of chromophore ⁇ in the investigated volume
  • the optical path length corresponds to the path length a photon travels along before reaching the sensor of an optical plethysmography setup, wherein the optical path length is a function of, among others, the wavelength of the incident light and of chromophore composition in the investigated volume, and wherein the optical path length is dependent on the distance between the light source emitting the photon and the sensor.
  • - G corresponds to a scattering dependent light intensity loss parameter and which depends on the wavelength l of the incident light emitted by the light source.
  • V i d corresponding to either a volume fraction or a concentration of chromophore ⁇ in the investigated volume at a first point in time along the optical plethysmography signal
  • V i s corresponding to either a volume fraction or a concentration of chromophore ⁇ in the investigated volume at a second point in time along the optical plethysmography signal;
  • I h corresponding to the light intensity measured by the sensor of the optical plethysmography setup at the first point in time;
  • equation (2) corresponding to the light intensity measured by the sensor of the optical plethysmography setup at the second point in time; the Beer-Lambert law as formulated in equation (1) can be evaluated at the first point in time and at the second point in time.
  • equation (3) is obtained by taking the natural logarithm of both sides of equation (2), as follows:
  • equation (3) If a logarithm with another base b than Euler’s number e is used, equation (3) then becomes:
  • Equation (3) can be simplified to equation (4) when when the difference V i s - V i d is being renamed AV U thereby obtaining:
  • Some chromophores remain attached to the epidermis of the individual between the two points in time along the optical plethysmography signal.
  • melanin molecules remain fixed to the investigated volume between the two points in time along the optical plethysmography signal.
  • the difference in either volume fraction or concentration of such chromophores, such as for example melanin molecules, between the two points in time is therefore null.
  • the contribution to the right-hand side of equation (4) of such chromophores is therefore null.
  • the main chromophores of which either the volume fraction or the concentration fluctuates between the two points in time along the optical plethysmography signal are the oxygenated and deoxygenated hemoglobin in the arterial blood volume.
  • equation (4) can then be rewritten as follows into equation (5): [29] It is known that the oxygen saturation estimate can be defined according to equation (6):
  • V Mood is defined as the total volume fraction or the total concentration of oxygenated and deoxygenated hemoglobin comprised within the arterial blood in the investigated volume and is defined as follows in equation (7):
  • Two predetermined calibration coefficients Q ⁇ and Q 2 which are two constants, can be defined as follows:
  • equation (10) After rewriting equation (9) in view of the two predetermined calibration coefficients Q ⁇ and Q 2 , equation (10) can be obtained, wherein the left-hand side of equation (10) corresponds to an evaluation function, and wherein Q 1 Sp0 2 + Q 2 corresponds to a compensation function which is a function of the oxygen saturation estimate:
  • Equation (10) highlights a term on the left-hand side, referred to as the evaluation function, which shows a linear relationship with:
  • AV bl00d is a linear proxy for arterial blood volume fluctuations within the investigated volume, and hence corresponds to a measurement of peripheral arterial tone.
  • the function of the light intensities corresponds to a ratio of the light intensities.
  • the evaluation function corresponds to the natural logarithm of a function of the light intensities.
  • any other evaluation function defined as a function of the light intensities could be used, for example a linear approximation of the logarithm of a function of the light intensities, or for example a Taylor series approximation of a function of the light intensities, or for example a linear approximation of other base logarithms of a function of the light intensities.
  • the evaluation function corresponds approximately to the ratio of the pulsatile waveform or AC component of the optical plethysmography signal and of the slowly varying baseline or DC component of the optical plethysmography signal, resulting in equation (13):
  • the evaluation function corresponds to a logarithm of a ratio of the light intensities; and the evaluation function depends on one or more of the following:
  • At least one of the points in time corresponds to the diastole in a cardiac cycle of the individual and/or wherein at least one of the points in time corresponds to the systole in a cardiac cycle of the individual.
  • the volume of arterial blood in the investigated volume of the individual is maximum, resulting in the largest absorption and scattering of light of any point in time within a cardiac cycle, i.e. the period between two heart beats, since hemoglobin is one of the main absorbers and scatters of photons in the investigated volume, hence resulting in the lowest measured light intensity on the sensor of the optical plethysmography setup.
  • the volume of arterial blood in the investigated volume of the individual is minimum, resulting in the lowest absorption and scattering of light of any point in time within a cardiac cycle and hence highest measured light intensity on the sensor of the optical plethysmography setup.
  • At least one first point in time corresponds for example to the diastole in a first cardiac cycle and/or at least one second point in time corresponds for example to the systole in a second cardiac cycle different from the first cardiac cycle.
  • at least one first point in time corresponds for example to the systole in a first cardiac cycle and/or at least one second point in time corresponds for example to the diastole in a second cardiac cycle different from the first cardiac cycle.
  • at least one first point in time corresponds for example to the systole or to the diastole in a cardiac cycle and at least one second point in time corresponds to any point in time within the same cardiac cycle or within a different cardiac cycle.
  • the method further comprises the steps of:
  • Optical plethysmography technology uses a simple and noninvasive setup probe or biosensor.
  • the optical plethysmography biosensor non-invasively measures pulsatile arterial volume changes in the investigated volume, and thereby assesses PAT, by collecting the optical plethysmography signal.
  • the light source is for example a LED or any other suitable light source which can be miniaturized to fit in the optical plethysmography biosensor.
  • the wavelength is for example comprised in the red spectrum. Alternatively, the wavelength is comprised in the infra-red spectrum.
  • a physical distance between the light sources and the sensor is for example a few millimeters, such as for example less than 3mm.
  • an apparatus comprising at least one processor and at least one memory including computer program code, the at least one memory and computer program code configured to, with the at least one processor, cause the apparatus to perform:
  • the apparatus according to the present disclosure allows determining peripheral arterial tone in an accurate and robust manner.
  • determining a logarithm or a function approximation therefore of a function of the light intensities the determination of changes in arterial blood volume in the investigated volume between two points in time with the apparatus according to the present disclosure is more accurate than by monitoring changes in amplitude of pulses in the optical plethysmography signal. Therefore, with the apparatus according to the present disclosure, it becomes possible to assess PAT of an individual more accurately and more robustly than with existing prior art solutions.
  • the resulting evaluation of changes in arterial blood volume in the investigated volume through the determination of a logarithm or a function approximation thereof of a function of the light intensities therefore provides a more accurate and robust assessment of peripheral arterial tone of the individual.
  • a system comprising an apparatus according to a second example aspect of the invention, and further comprises:
  • a sensor configured to collect by optical plethysmography propagated light corresponding to the light being transmitted or reflected when propagating in the investigated volume of the individual at the two or more points in time; and further configured to determine the light intensities of the propagated light at the two or more points in time.
  • the sensor collects propagated light by optical plethysmography, wherein the propagated light corresponds to the light being transmitted or reflected when propagating in the investigated volume of the individual, such as for example a distal end of a digit of the individual, at the two or more points in time.
  • the system further optionally comprises a wireless transmitter comprising a wireless communication interface, wherein the wireless transmitter is configured to transmit the determined peripheral arterial tone wirelessly for further processing by the apparatus.
  • the wireless communication interface is preferably a low power communication interface, e.g. a Bluetooth Low Energy, BLE, wireless interface.
  • a computer program product comprising computer-executable instructions for causing a system to perform at least the following is provided:
  • a computer readable storage medium comprises computer- executable instructions for performing the following steps when the program is run on a computer:
  • a use of a logarithm or a function approximation thereof for assessing peripheral arterial tone, PAT, of an individual monitored by optical plethysmography and for detecting therefrom occurrence of a sleep-related event at the individual, comprises:
  • FIG. 1 depicts an example embodiment of an apparatus according to the present disclosure.
  • FIG. 2 depicts an example embodiment of a system according to the present disclosure comprising an apparatus according to the present disclosure.
  • FIG. 3 depicts an example embodiment of a system according to the present disclosure comprising an apparatus according to the present disclosure.
  • FIG. 4 depicts an example embodiment of a comparison of a PAT measurement of an individual assessed by an apparatus according to the present disclosure and assessed without determining a logarithm of a function of the light intensities.
  • FIG. 5 depicts an example embodiment of a computer-implemented method according to the present disclosure.
  • Fig. 6 shows an example embodiment of a suitable computing system for performing one or several steps in embodiments of the invention.
  • Fig. 1 illustrates an example embodiment of an apparatus 10 according to the present disclosure.
  • the apparatus 10 comprises at least one memory 6, at least one processor, wherein the memory 6 includes computer program code configured to, with the at least one processor, cause the apparatus 10 to perform the following:
  • the apparatus 10 obtains the optical plethysmography signal 101 and/or the light intensities 102; 103 from an external device. According to an alternative embodiment, the apparatus 10 obtains the optical plethysmography signal 101 and/or the light intensities 102; 103 from the memory 6. According to a further alternative embodiment, the apparatus 10 the optical plethysmography signal 101 and/or the light intensities 102; 103 from the memory 6 and/or from an external device.
  • at least one point in time 12 corresponds to the diastole of a cardiac cycle of the individual and/or at least one point in time 13 corresponds to the systole of a cardiac cycle of the individual.
  • the apparatus 10 is configured to determine an evaluation function 17 which corresponds to a logarithm 17 or a function approximation thereof 17 of a function of the light intensities 102; 103.
  • the evaluation function 17 depends on one or more of the following: an optical path length, a function of the oxygen saturation estimate, a change in arterial blood volume in the investigated volume.
  • Fig. 2 illustrates an example embodiment of a system 20 according to the present disclosure. Components having identical reference numbers to numbers on Fig. 1 perform the same function.
  • the system 20 of Fig. 2 comprises an apparatus 10 according to the present disclosure.
  • the system 20 further comprises a light source 2 and a sensor 4.
  • a light source 2 is configured to emit light 40.
  • the apparatus 10 is configured to:
  • the apparatus 10 obtains the optical plethysmography signal 101 and/or the light intensities 102; 103 from an external device from an external device 200 comprising at least one light source 2 and/or the sensor 4.
  • the external device 200 determines the arterial blood volume pulse in the investigated volume 11 of the individual 1.
  • the external device 200 comprises a battery for powering the different electrical components 2;4.
  • the light source 2 is configured to emit light, i.e. to transmit the light 40 into the investigated volume 11 of the individual attached to the external device 200, for example into the finger 11 of the individual 1 as illustrated, more particularly to a distal end 11 of a finger of the individual.
  • the external device 200 further comprises control circuitry for controlling the light source 2, i.e., for enabling or disabling the light source 2 and for receiving the measurements for example of the light intensities from the sensor 4.
  • Control circuitry may further comprise a memory component for temporarily storing the obtained measurements.
  • Control circuitry is further coupled to a wireless interfacing circuitry 50 and configured to forward the measurements to the wireless interfacing circuitry 50.
  • Wireless interface 50 may support a short range and/or low power wireless communication protocol for efficient transmission of the measurements to a receiving part of the system. Wireless interface 50 may for example operate according to the Bluetooth Low Energy, BLE, protocol as defined by the Bluetooth Special Interest Group or according to a Near Field Communication, NFC, protocol.
  • the apparatus 10 obtains the optical plethysmography signal 101 and/or the light intensities 102; 103 from the memory 6.
  • the apparatus 10 the optical plethysmography signal 101 and/or the light intensities 102; 103 from the memory 6 and/or from an external device.
  • at least one point in time 12 corresponds to the diastole of a cardiac cycle of the individual and/or at least one point in time 13 corresponds to the systole of a cardiac cycle of the individual.
  • the apparatus 10 is configured to determine an evaluation function 17 which is a function of the light intensities 102; 103.
  • the external device 200 collects, by optical plethysmography on the sensor 4, propagated light 41 corresponding to light 40 emitted by the light source 2, wherein the light 40 is transmitted or reflected by the investigated volume 11 when propagating in the distal end of the digit of the individual 1 at the two or more points in time 12; 13 along the optical plethysmography signal 101.
  • the external device 200 collects, by optical plethysmography on the sensor 4, a light intensity 102 corresponding to propagated light 41 corresponding to light 40 emitted by the light source 2, wherein the light 40 is transmitted or reflected by the investigated volume 11 when propagating in the distal end of the digit of the individual 1 and is collected on the sensor 4 at a first point in time 12; and the external device 200 collects, by optical plethysmography on the sensor 4, a light intensity 103 corresponding to propagated light 41 corresponding to light 40 emitted by the same light source 2, wherein the light 40 is transmitted or reflected by the investigated volume 11 when propagating in the distal end of the digit of the individual 1 and is collected on the sensor 4 at a second point in time 13.
  • the apparatus determines an evaluation function 17.
  • the evaluation function 17 for example corresponds to a logarithm of a function of the light intensities 102; 103.
  • the evaluation function 17 for example corresponds to a logarithm of a ratio of the light intensities 102; 103.
  • the evaluation function 17 depends on one or more of the following: an optical path length, a function of the oxygen saturation estimate, a change in arterial blood volume in the investigated volume.
  • Fig. 3 illustrates an example embodiment of a system 20 according to the present disclosure. Components having identical reference numbers to numbers on Fig. 1 or Fig. 2 perform the same function.
  • the system 20 of Fig. 3 comprises an apparatus 10 according to the present disclosure.
  • the system 20 further comprises at least one light source 2 and a sensor 4, comprised in the apparatus 10.
  • a light source 2 is configured to emit light 40.
  • the apparatus 10 is configured to:
  • the apparatus 10 obtains the optical plethysmography signal 101 and/or the light intensities 102; 103 from the light source 2 and/or the sensor 4. For example, the apparatus 10 determines the arterial blood volume pulse in the investigated volume 11 of the individual 1.
  • the apparatus 10 comprises a battery for powering the different electrical components 2;3;4.
  • the light source 2 is configured to emit light, i.e. to transmit the light 40 into the investigated volume 11 of the individual attached to the apparatus 10, for example into the finger 11 of the individual 1 as illustrated, more particularly to a distal end 11 of a finger of the individual as illustrated.
  • the apparatus 10 further comprises control circuitry for controlling the light source 2, i.e., for enabling or disabling the light source 2 and for receiving the measured arterial blood volume pulse values from the sensor 4.
  • Control circuitry may further comprise a memory component for temporarily storing the obtained measurements.
  • Control circuitry is further coupled to a wireless interfacing circuitry 50 and configured to forward the measurements to the wireless interfacing circuitry 50.
  • Wireless interface 50 may support a short range and/or low power wireless communication protocol for efficient transmission of the measurements to a receiving part of the system.
  • Wireless interface 50 may for example operate according to the Bluetooth Low Energy, BLE, protocol as defined by the Bluetooth Special Interest Group or according to a Near Field Communication, NFC, protocol. Operation by such protocols together with forwarding of the raw optical plethysmography signal 101 allows miniaturization of the apparatus 10 such that it fits on a finger or a nostril and allows operation during multiple nights.
  • the apparatus 10 obtains one or more of the optical plethysmography signal 101 , the light intensities 102; 103 from the memory 6. According to a further alternative embodiment, the apparatus 10 obtains one or more of the optical plethysmography signal 101 , the light intensities 102; 103 from the light source 2 and/or the sensor 4 and/or from the memory 6.
  • at least one point in time 12 corresponds to the diastole of a cardiac cycle of the individual and/or at least one point in time 13 corresponds to the systole of a cardiac cycle of the individual.
  • the apparatus 10 is configured to determine an evaluation function 17 which is a function of the light intensities 102; 103.
  • the apparatus 10 collects, by optical plethysmography on the sensor 4, propagated light 41 corresponding to light 40 emitted by the light source 2, wherein the light 40 is transmitted or reflected by the investigated volume 11 when propagating in the distal end of the digit of the individual at the two or more points in time 12; 13 along the optical plethysmography signal 101.
  • the apparatus 10 collects, by optical plethysmography on the sensor 4, a light intensity 102 corresponding to propagated light 41 corresponding to light 40 emitted by the light source 2, wherein the light 40 is transmitted or reflected by the investigated volume 11 when propagating in the distal end of the digit of the individual 1 and is collected on the sensor 4 at a first point in time 12; and the apparatus 10 collects, by optical plethysmography on the sensor 4, a light intensity 103 corresponding to propagated light 41 corresponding to light 40 emitted by the same light source 2, wherein the light 40 is transmitted or reflected by the investigated volume 11 when propagating in the distal end of the digit of the individual 1 and is collected on the sensor 4 at a second point in time 13.
  • the apparatus determines an evaluation function 17.
  • the evaluation function 17 for example corresponds to a logarithm of a function of the light intensities 102; 103.
  • the evaluation function 17 for example corresponds to a logarithm of a ratio of the light intensities 102; 103.
  • the evaluation function 17 depends on one or more of the following: an optical path length, a function of the oxygen saturation estimate, a change in arterial blood volume in the investigated volume.
  • Fig. 4 illustrates an example comparison between PPG-amplitude-based peripheral arterial tone 401 both in function of time 60 of an individual, wherein the PPG-amplitude-based peripheral arterial tone 401 is assessed by considering changes in amplitude of pulses in an optical plethysmography signal as described in the prior art, and evaluation-function-based peripheral arterial tone 402 in function of time 60 of the same individual, wherein the evaluation-function-based peripheral arterial tone 402 is determined by the computer-implemented method according to the present disclosure, or by the apparatus according to the present disclosure, i.e. wherein the evaluation-function-based peripheral arterial tone 402 is assessed by determining a logarithm of a ratio of light intensities measured from an optical plethysmography signal.
  • the evaluation-function-based peripheral arterial tone 402 is plotted by calculating ⁇ ( ) ⁇
  • the evaluation-function-based peripheral arterial tone 402 is plotted by calculating
  • the PPG-amplitude-based peripheral arterial tone 401 and the evaluation-function-based peripheral arterial tone 402 evolve in a similar manner as a function of time 60 at a pre-vasoconstriction-event baseline value. But during the time periods 61 and 62, i.e. during occurrence of an event such as for example a sleep- related event, such as for example a sleep related respiratory event, it can be seen on Fig. 4 that the PPG-amplitude-based peripheral arterial tone 401 and the evaluation- function-based peripheral arterial tone 402 evolve in a similar manner but do not overlap anymore in the corresponding time periods 61 and 62.
  • the PPG-amplitude-based peripheral arterial tone 401 drops to a level 403 which value is higher than the one of the level 404 to which the evaluation-function-based peripheral arterial tone 402 drops.
  • the PPG-amplitude-based peripheral arterial tone 401 drops to a level 405 which value is higher than the one of the level 406 to which the evaluation-function-based peripheral arterial tone 402 drops. It can be seen on Fig. 4 that assessing peripheral arterial tone 100 by determining a logarithm of a function of light intensities acquired by optical plethysmography allows to detect the event occurring more accurately.
  • a drop in peripheral arterial tone 100 is indicative for a vasoconstriction of the arteries and the arterioles in the investigated volume under monitoring.
  • This vasoconstriction can be related to the occurrence of an event at the individual under monitoring such as for example a sleep- related event, such as for example sleep apnea.
  • the drop in the PPG-amplitude-based peripheral arterial tone 401 between the pre- vasoconstriction-event baseline value and the lowest point of the PPG-amplitude- based peripheral arterial tone 401 is smaller than the drop in the evaluation-function- based peripheral arterial tone 402 between the pre-vasoconstriction-event baseline value and the lowest point of the evaluation-function-based peripheral arterial tone 402.
  • a predetermined threshold value 407 for peripheral arterial tone 100 can be used to detect whether an event is occurring at the individual under monitoring such as for example a sleep-related event, such as for example sleep apnea: when the peripheral arterial tone 100 is above this predetermined threshold value 407, no event is detected, but when the peripheral arterial tone 100 is below this predetermined threshold value 407, an event is detected.
  • a sleep-related event such as for example sleep apnea
  • the drop in the PPG-amplitude-based peripheral arterial tone 401 between the pre-vasoconstriction-event baseline value and the lowest point of the PPG-amplitude-based peripheral arterial tone 401 is such that the PPG-amplitude-based peripheral arterial tone 401 stays above the predetermined threshold value 407, which results in the absence of detection of an event occurring at the individual under monitoring such as for example a sleep-related event, such as for example sleep apnea.
  • the drop in the evaluation-function-based peripheral arterial tone 402 between the pre-vasoconstriction-event baseline value and the lowest point of the evaluation-function-based peripheral arterial tone 402 is such that the evaluation-function-based peripheral arterial tone 402 drops below the predetermined threshold value 407, which results in the detection of an event occurring at the individual under monitoring such as for example a sleep-related event, such as for example sleep apnea.
  • peripheral arterial tone 100 by determining a logarithm of a function of light intensities acquired by optical plethysmography allows to more accurately and more robustly detect the occurrence of an event occurring at the individual under monitoring such as for example a sleep- related event, such as for example sleep apnea.
  • FIG. 5 illustrates an example embodiment of a computer-implemented method for assessing peripheral arterial tone, PAT, of an individual monitored by optical plethysmography, wherein said method comprises the steps of:
  • a first step 501 obtaining: o an optical plethysmography signal 101 measured at an investigated volume 11 of the individual 1 ; and o light intensities 102; 103 acquired by optical plethysmography at two or more points in time 12; 13 along the optical plethysmography signal 101 ; and
  • a third step 503 consecutive to the second step 502, determining a drop in the PAT 100 indicative for a vasoconstriction of arteries and arterioles in the investigated volume 11 , thereby detecting occurrence of a sleep-related event at the individual 1.
  • FIG. 6 shows a suitable computing system 800 enabling to implement embodiments of the system.
  • Computing system 800 may in general be formed as a suitable general-purpose computer and comprise a bus 810, a processor 802, a local memory 804, one or more optional input interfaces 814, one or more optional output interfaces 816, a communication interface 812, a storage element interface 806, and one or more storage elements 808.
  • Bus 810 may comprise one or more conductors that permit communication among the components of the computing system 800.
  • Processor 802 may include any type of conventional processor or microprocessor that interprets and executes programming instructions.
  • Local memory 804 may include a random-access memory (RAM) or another type of dynamic storage device that stores information and instructions for execution by processor 802 and/or a read only memory (ROM) or another type of static storage device that stores static information and instructions for use by processor 802.
  • Input interface 814 may comprise one or more conventional mechanisms that permit an operator or user to input information to the computing device 800, such as a keyboard 820, a mouse 830, a pen, voice recognition and/or biometric mechanisms, a camera, etc.
  • Output interface 816 may comprise one or more conventional mechanisms that output information to the operator or user, such as a display 840, etc.
  • Communication interface 812 may comprise any transceiver-like mechanism such as for example one or more Ethernet interfaces that enables computing system 800 to communicate with other devices and/or systems, for example with other computing devices 881 , 882, 883.
  • the communication interface 812 of computing system 800 may be connected to such another computing system by means of a local area network (LAN) or a wide area network (WAN) such as for example the internet.
  • Storage element interface 806 may comprise a storage interface such as for example a Serial Advanced Technology Attachment (SATA) interface or a Small Computer System Interface (SCSI) for connecting bus 810 to one or more storage elements 808, such as one or more local disks, for example SATA disk drives, and control the reading and writing of data to and/or from these storage elements 808.
  • SATA Serial Advanced Technology Attachment
  • SCSI Small Computer System Interface
  • computing system 800 could thus correspond to the apparatus 10 in the embodiment illustrated by Figs. 1 or 2 or 3.
  • circuitry may refer to one or more or all of the following:
  • any portions of hardware processor(s) with software including digital signal processor(s)), software, and memory(ies) that work together to cause an apparatus, such as a mobile phone or server, to perform various functions
  • hardware circuit(s) and/or processor(s) such as microprocessor(s) or a portion of a microprocessor(s), that requires software (e.g. firmware) for operation, but the software may not be present when it is not needed for operation.
  • circuitry also covers an implementation of merely a hardware circuit or processor (or multiple processors) or portion of a hardware circuit or processor and its (or their) accompanying software and/or firmware.
  • circuitry also covers, for example and if applicable to the particular claim element, a baseband integrated circuit or processor integrated circuit for a mobile device ora similar integrated circuit in a server, a cellular network device, or other computing or network device.
  • top, bottom, over, under, and the like are introduced for descriptive purposes and not necessarily to denote relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and embodiments of the invention are capable of operating according to the present invention in other sequences, or in orientations different from the one(s) described or illustrated above.

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Abstract

L'invention concerne un procédé mis en oeuvre par ordinateur destiné à évaluer le tonus artériel périphérique (100), TAP, d'un individu (1) surveillé par pléthysmographie optique, et à détecter à partir de celui-ci l'apparition d'un événement lié au sommeil, comprenant : - l'obtention : o d'un signal de pléthysmographie optique (101) mesuré à un volume étudié (11) ; et o d'intensités lumineuses (102 ; 103) acquises à au moins deux points dans le temps (12 ; 13) le long dudit signal de pléthysmographie optique (101) ; la détermination de changements dans le volume sanguin artériel (16) dans ledit volume étudié (11) entre lesdits au moins deux points dans le temps (12 ; 13) par détermination d'un logarithme (17) ou d'une approximation de fonction de celui-ci (17) d'une fonction desdites intensités lumineuses (102 ; 103), ce qui permet d'évaluer le TAP (100) dudit individu (1) ; et - la détermination d'une chute dans ledit TAP (100) indicative d'une vasoconstriction des artères et des artérioles dans ledit volume étudié (11), ce qui permet de détecter l'apparition d'un événement lié au sommeil.
PCT/EP2021/067534 2020-06-26 2021-06-25 Procédé et appareil pour évaluer le tonus artériel périphérique WO2021260192A1 (fr)

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US18/012,009 US20230263453A1 (en) 2020-06-26 2021-06-25 Method and apparatus for assessing peripheral arterial tone
AU2021295604A AU2021295604A1 (en) 2020-06-26 2021-06-25 Method and apparatus for assessing peripheral arterial tone
JP2022580956A JP2023532318A (ja) 2020-06-26 2021-06-25 末梢動脈緊張を評価するための方法及び装置
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US20220202359A1 (en) * 2020-12-30 2022-06-30 Itamar Medical, Ltd. System and method for arrhythmia detection during an at home sleep test
WO2023031802A1 (fr) 2021-08-30 2023-03-09 Resmed Sensor Technologies Limited Entraînement respiratoire intelligent
WO2023148190A1 (fr) * 2022-02-03 2023-08-10 Ectosense NV Systèmes et procédés de criblage, de diagnostic, de détection, de surveillance et/ou de thérapie

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US20220202359A1 (en) * 2020-12-30 2022-06-30 Itamar Medical, Ltd. System and method for arrhythmia detection during an at home sleep test
WO2023031802A1 (fr) 2021-08-30 2023-03-09 Resmed Sensor Technologies Limited Entraînement respiratoire intelligent
WO2023148190A1 (fr) * 2022-02-03 2023-08-10 Ectosense NV Systèmes et procédés de criblage, de diagnostic, de détection, de surveillance et/ou de thérapie

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JP2023532318A (ja) 2023-07-27
IL299330A (en) 2023-02-01

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